Back to resultsAZD6765 for Treatment Resistant Depression
Primary Purpose
Depression
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AZD6765
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Long-term depression
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Depression
- Inadequate response to an adequate course of antidepressants
Exclusion Criteria:
- Psychiatric disorder other than depression
- Pregnancy or lactation
- Current diagnosis of cancer
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
The primary objective is to determine whether an antidepressant effect can be achieved in patients with Treatment Resistant Depression determined by a change from baseline in the MADRS total score.
Secondary Outcome Measures
The secondary objective is to assess the safety and tolerability of AZD6765 as assessed by vital signs, physical examination, clinical laboratory evaluations, ECG's and incidence of adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00491686
Brief Title
AZD6765 for Treatment Resistant Depression
Official Title
A Phase IIa, Multi-Center, Randomized, Double-blind, Placebo-controlled, Parallel-Group Study to Assess the Antidepressant Effect and Onset of Effect of AZD6765 in Treatment-Resistant Major Depressive Disorder Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether treatment with AZD6765 will have an antidepressant effect with patients who have treatment resistant depression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Long-term depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AZD6765
Intervention Description
intravenous infusion
Primary Outcome Measure Information:
Title
The primary objective is to determine whether an antidepressant effect can be achieved in patients with Treatment Resistant Depression determined by a change from baseline in the MADRS total score.
Time Frame
Change from Baseline
Secondary Outcome Measure Information:
Title
The secondary objective is to assess the safety and tolerability of AZD6765 as assessed by vital signs, physical examination, clinical laboratory evaluations, ECG's and incidence of adverse events.
Time Frame
each visit; change from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Depression
Inadequate response to an adequate course of antidepressants
Exclusion Criteria:
Psychiatric disorder other than depression
Pregnancy or lactation
Current diagnosis of cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Smith, MD, PhD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Glendale
State/Province
California
Country
United States
Facility Name
Research Site
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Research Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
Rockville
State/Province
Maryland
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34510411
Citation
Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.
Results Reference
derived
PubMed Identifier
24126931
Citation
Sanacora G, Smith MA, Pathak S, Su HL, Boeijinga PH, McCarthy DJ, Quirk MC. Lanicemine: a low-trapping NMDA channel blocker produces sustained antidepressant efficacy with minimal psychotomimetic adverse effects. Mol Psychiatry. 2014 Sep;19(9):978-85. doi: 10.1038/mp.2013.130. Epub 2013 Oct 15.
Results Reference
derived
Learn more about this trial
AZD6765 for Treatment Resistant Depression
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